FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN/EXT DL
MDR report key: 2904714
·
Received January 4, 2013
Report
- Report Number
- 8030665-2013-00005
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Date of Event
- December 8, 2012
- Report Date
- December 8, 2012
- Manufacturer
- REYNOSA MANUFACTURING
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A PERITONEAL DIALYSIS PT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PT WAS IN DRAIN FIVE OF FIVE. UPON OPENING THE CASSETTE DOOR FOLLOWING TREATMENT, THE PT NOTICED FLUID LEAKING INTO THE CYCLER. THE ORIGIN OF THE LEAK COULD NOT BE IDENTIFIED. PT HAD NO ILL EFFECTS. SAMPLE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5342 | LIBERTY CYCLER SET, SINGLE CONN/EXT DL | LIBERTY DIALYSIS CYCLER TUBING | FKX | REYNOSA MANUFACTURING | 12LR08018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY DIALYSIS CYCLER |